Further your career at this Pharma-Powerhouse client with this remote opportunity. If you're looking to do more with you pharmacovigilence experience and put it to work in a global environment, matrix environment. This is this an opportunity that can't be looked over.
location: Northbrook, Illinois
job type: Contract
salary: $68 - 74 per hour
work hours: 8 to 4
education: High School
- Create and maintain the Global periodics schedule by interfacing with external departments.
- Work with affiliates and local health authorities to understand periodic reporting requirements.
- Negotiate with local health authorities to leverage existing reports and periodicities to meet the periodic reporting requirements
- Regularly work with EU-Regulatory Affairs to update and maintain the global periodics schedule
- Coordinate periodic schedule information from multiple sources
- Project management for Aggregate Safety Assessment (ASA) initiatives, maintain ASA SharePoint (SPS), take meeting minutes, etc.
- Coordinate periodic reports, work with external global vendor in the development of periodic reports.
- Work with product responsible persons/ physicians and other stakeholders to ensure that periodic reports comply with the timelines and regulations.
- Assist project teams in updating global and local controlled documents
- Manage high volume of work generated from multiple regions.
- Manage the controlled document approval process (review, approval, signatories)
- Develop training content based on updates made to controlled documents.
- Perform writing and project management activities for documents (e.g., PBRER, DSUR) including formatting text, tables, and appendices, apply styles, hyperlinking, versioning, Table of Contents, etc.
- Assist with alternative wording, presentation, or style to ensure clarity of content.
- Assist with issue resolution related to the document content.
- Coordinate editing activities.
- Compile source/supporting documentation for the quality control review process.
- When necessary, manage the project timelines and deliverables of aggregate report projects (e.g., PADERs) working closely with the Safety Team.
- Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources of medical/scientific information for aggregate reports (e.g., PBRERs, DSURs, etc.).
- Recommend changes for the QC findings
- Record QC metrics per defined categories
- Hands on, relevant experience with controlled documents
- Knowledge of PV SOPs and/or processes required
- Ability to work effectively with remote team members
- Must be able to work independently with minimal supervision.
- Excellent organization skills.
- Proficiency in MS Office Products required.
- Excellent written and oral communication skills.
- Strong leadership skills
- Expert in Word, PowerPoint, Excel, and Adobe
- Excellent listening and comprehension skills
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
- Thorough knowledge of GVP modules and ICH PV regulations
- Proven project management skills and attributes evidenced by detailed project management experience.
- Highly organized
- Experience writing periodic reports, QC experience, process oversight experience, and process creation experience
- Minimum 5 years of relevant experience in PV
skills: MS-EXCEL, Drug Safety, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.